Clinical Trials

Study : NANT 99-02

BSO + L-PAM and Stem Cell Support

Phase I Study:

Modulation of Intensive Melphalan (L-PAM) by Buthionine Sulfoximine (BSO) (NSC-326321) and Autologous Stem Cell Support For Recurrent High Risk Neuroblastoma (NCI 68).

Study Chair:  Judith Villablanca, MD (CHLA).

What is this study about:

This study uses a new combination of two anti-cancer drugs, Buthionine Sulfoximine (BSO) given with melphalan followed by autologous stem cell support to try to get rid of any remaining cancer cells.

• Melphalan is a traditional anti cancer agent that is effective in neuroblastoma.
• BSO is a new drug that has been shown in the laboratory to increase the number of neuroblastoma cancer cells that are killed when BSO is used together with melphlan.
• It is hoped that giving BSO together with melphalan will kill more neuroblastoma cancer cells than melphalan would by itself.

Why is this study being done:

• To find the highest dose of melphalan that can be given with BSO without causing severe side effects.
• To measure the blood levels of melphalan and BSO during treatment.
• To determine if the neuroblastoma tumor gets smaller after getting this treatment.

Criteria which need to be met to participate in this study:

• Patients have relapsed neuroblastoma and must have exhausted all other options for treatment before they can be considered for treatment on this study.
• Relapsed patients who are greater than 6 months since having a stem cell transplant can enter on this study.
• Patients must have stem cells collected and stored before starting treatment.
• Patients must have a double lumen central venous line in place.
• Patients must have adequate kidney and liver function measured by blood tests and test of renal function (creatinine clearance or glomerular filtration rate (GFR)).
• Patients must have normal heart and lung function measured by lack of physical evidence or clinical history of difficulties breathing and tests of cardiac function (Echocardiogram or MUGA evaluation).
• Patients must have an essentially normal neurological exam.
• Patients must have one entire kidney that has not had any radiation at treatment doses. (Xrays and scans are ok).
• Patients must have recovered from the effects of any prior treatment for their tumor.

Patients cannot participate in this study if:

• They have had any radiation therapy to the brain.
• They have known history of or current tumor found in the brain or surrounding tissues.
• They have a history of seizures.
• They have a history of changes in a test of kidney function with antibiotic use in the 6 months immediately before entering on this study.

If you would like to download or print a sample consent form for this clinical trial, please click here : N9902_Prt_amd5_v7-09-05_informed_consent.pdf

If you would like to download or watch a video describing this clinical trial, please click here: N99-02 video

[ If you are interested in getting more information about this clinical trial, please click here to send us an email. ]